Establishing Rigorous and Cost-effective Clinical Trials for Artificial Intelligence Models

Fuente: arXiv
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Autori principali: Gao, Wanling, Huang, Yunyou, Cui, Dandan, Yu, Zhuoming, Liu, Wenjing, Liang, Xiaoshuang, Zhao, Jiahui, Xie, Jiyue, Li, Hao, Ma, Li, Ye, Ning, Kang, Yumiao, Luo, Dingfeng, Pan, Peng, Huang, Wei, Liu, Zhongmou, Hu, Jizhong, Zhao, Gangyuan, Jiang, Chongrong, Huang, Fan, Wei, Tianyi, Tang, Suqin, Xia, Bingjie, Zhang, Zhifei, Zhan, Jianfeng
Natura: Preprint
Pubblicazione: 2024
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author Gao, Wanling
Huang, Yunyou
Cui, Dandan
Yu, Zhuoming
Liu, Wenjing
Liang, Xiaoshuang
Zhao, Jiahui
Xie, Jiyue
Li, Hao
Ma, Li
Ye, Ning
Kang, Yumiao
Luo, Dingfeng
Pan, Peng
Huang, Wei
Liu, Zhongmou
Hu, Jizhong
Zhao, Gangyuan
Jiang, Chongrong
Huang, Fan
Wei, Tianyi
Tang, Suqin
Xia, Bingjie
Zhang, Zhifei
Zhan, Jianfeng
author_facet Gao, Wanling
Huang, Yunyou
Cui, Dandan
Yu, Zhuoming
Liu, Wenjing
Liang, Xiaoshuang
Zhao, Jiahui
Xie, Jiyue
Li, Hao
Ma, Li
Ye, Ning
Kang, Yumiao
Luo, Dingfeng
Pan, Peng
Huang, Wei
Liu, Zhongmou
Hu, Jizhong
Zhao, Gangyuan
Jiang, Chongrong
Huang, Fan
Wei, Tianyi
Tang, Suqin
Xia, Bingjie
Zhang, Zhifei
Zhan, Jianfeng
contents A profound gap persists between artificial intelligence (AI) and clinical practice in medicine, primarily due to the lack of rigorous and cost-effective evaluation methodologies. State-of-the-art and state-of-the-practice AI model evaluations are limited to laboratory studies on medical datasets or direct clinical trials with no or solely patient-centered controls. Moreover, the crucial role of clinicians in collaborating with AI, pivotal for determining its impact on clinical practice, is often overlooked. For the first time, we emphasize the critical necessity for rigorous and cost-effective evaluation methodologies for AI models in clinical practice, featuring patient/clinician-centered (dual-centered) AI randomized controlled trials (DC-AI RCTs) and virtual clinician-based in-silico trials (VC-MedAI) as an effective proxy for DC-AI RCTs. Leveraging 7500 diagnosis records from two-step inaugural DC-AI RCTs across 14 medical centers with 125 clinicians, our results demonstrate the necessity of DC-AI RCTs and the effectiveness of VC-MedAI. Notably, VC-MedAI performs comparably to human clinicians, replicating insights and conclusions from prospective DC-AI RCTs. We envision DC-AI RCTs and VC-MedAI as pivotal advancements, presenting innovative and transformative evaluation methodologies for AI models in clinical practice, offering a preclinical-like setting mirroring conventional medicine, and reshaping development paradigms in a cost-effective and fast-iterative manner. Chinese Clinical Trial Registration: ChiCTR2400086816.
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id arxiv_https___arxiv_org_abs_2407_08554
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publishDate 2024
record_format arxiv
spellingShingle Establishing Rigorous and Cost-effective Clinical Trials for Artificial Intelligence Models
Gao, Wanling
Huang, Yunyou
Cui, Dandan
Yu, Zhuoming
Liu, Wenjing
Liang, Xiaoshuang
Zhao, Jiahui
Xie, Jiyue
Li, Hao
Ma, Li
Ye, Ning
Kang, Yumiao
Luo, Dingfeng
Pan, Peng
Huang, Wei
Liu, Zhongmou
Hu, Jizhong
Zhao, Gangyuan
Jiang, Chongrong
Huang, Fan
Wei, Tianyi
Tang, Suqin
Xia, Bingjie
Zhang, Zhifei
Zhan, Jianfeng
Artificial Intelligence
Human-Computer Interaction
A profound gap persists between artificial intelligence (AI) and clinical practice in medicine, primarily due to the lack of rigorous and cost-effective evaluation methodologies. State-of-the-art and state-of-the-practice AI model evaluations are limited to laboratory studies on medical datasets or direct clinical trials with no or solely patient-centered controls. Moreover, the crucial role of clinicians in collaborating with AI, pivotal for determining its impact on clinical practice, is often overlooked. For the first time, we emphasize the critical necessity for rigorous and cost-effective evaluation methodologies for AI models in clinical practice, featuring patient/clinician-centered (dual-centered) AI randomized controlled trials (DC-AI RCTs) and virtual clinician-based in-silico trials (VC-MedAI) as an effective proxy for DC-AI RCTs. Leveraging 7500 diagnosis records from two-step inaugural DC-AI RCTs across 14 medical centers with 125 clinicians, our results demonstrate the necessity of DC-AI RCTs and the effectiveness of VC-MedAI. Notably, VC-MedAI performs comparably to human clinicians, replicating insights and conclusions from prospective DC-AI RCTs. We envision DC-AI RCTs and VC-MedAI as pivotal advancements, presenting innovative and transformative evaluation methodologies for AI models in clinical practice, offering a preclinical-like setting mirroring conventional medicine, and reshaping development paradigms in a cost-effective and fast-iterative manner. Chinese Clinical Trial Registration: ChiCTR2400086816.
title Establishing Rigorous and Cost-effective Clinical Trials for Artificial Intelligence Models
topic Artificial Intelligence
Human-Computer Interaction
url https://arxiv.org/abs/2407.08554